Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices 3907

REGISTRATION: There is no registration

fee, however, space is limited. Persons

will be registered in the order in which

calls are received. Please call Betty B.

Palsgrove at 301–827–6618 to register.

Registrations also may be transmitted by

fax to 1–800–344–3332 or 301–443–

2446. Please include the name and title

of the person attending and the name of

the organization.

FOR FURTHER INFORMATION CONTACT:

Peter H. Rheinstein, M.D., J.D., Office of

Health Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6630.

SUPPLEMENTARY INFORMATION:

The purpose of the meeting is to

provide an opportunity for

representatives of health professional

organizations and other interested

persons to be briefed by senior FDA

staff. It will also provide an opportunity

for informal discussion on these topics

of particular interest to health

professional organizations.

This public meeting is free of charge;

however, space is limited. Registration

for the meeting will be accepted in the

order received and should be sent to the

contact person. Registration should

include the name and title of the person

attending and the name of the

organization being represented, if any.

Dated: January 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1850 Filed 1–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Imaging Drugs Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Medical Imaging

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on February 9, 1998, 8 a.m. to 5

p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Leander B. Madoo,

Center for Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–80–741–8138 (301–443–0572 in

the Washington, DC area), code 12540.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

the safety and efficacy of new drug

application (NDA) 20–887 AcuTectTM,

Diatide, Inc., a radiopharmaceutical

agent for the detection and localization

of acute venous thrombosis.

Procedure: On February 9, 1998, from

8 a.m. to 1 p.m. and from 2 p.m. to 5

p.m. the meeting is open to the public.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by February

2, 1998. Oral presentations from the

public will be scheduled between

approximately 8:30 a.m. and 9:30 a.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before February 2,

1998, and submit a brief statement of

the general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Closed Committee Deliberations: On

February 9, 1998, from 1 p.m. to 2 p.m.,

the meeting will be closed to permit

discussion and review of trade secret

and/or confidential information relating

to NDA 20–887 AcuTectTM (5 U.S.C.

552b(c)(4)).

FDA regrets that it was unable to

publish this notice 15 days prior to the

February 9, 1998, Medical Imaging

Drugs Advisory Committee meeting.

Because the agency believes there is

some urgency to bring this issue to

public discussion and qualified

members of the Medical Imaging Drugs

Advisory Committee were available at

this time, the Commissioner concluded

that it was in the public interest to hold

this meeting even if there was not

sufficient time for the customary 15-day

public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–2022 Filed 1–23–98; 11:47 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0017]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Draft Guidance on Validation of

Analytical Procedures: Definition and

Terminology (#63), and Validation of

Analytical Procedures: Methodolgy

(#64); Availability; Request for

Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of two draft

guidance for industry (GFI) documents

entitled ‘‘Validation of Analytical

Procedures: Definition and

Terminology’’ (number 63) and

‘‘Validation of Analytical Procedures:

Methodology’’ (number 64). These

related draft GFI documents have been

adapted for veterinary use by the

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH)

from two guidelines, Q2A and Q2B, that

were adopted by the International

Conference on Harmonisation (ICH) of

Technical Requirements for Registration

of Pharmaceuticals for Human Use. The

draft guidance is intended to provide

guidance on characteristics that should

be considered during the validation of

analytical procedures included as part

of registration applications for approval

of veterinary medicinal products

submitted to the European Union,

Japan, and the United States.

DATES: Submit written comments on

these draft GFI documents by March 30,

1998.

ADDRESSES: Submit written comments

on the two draft GFI documents to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm 1–23, Rockville,

MD 20857. Comments should be

identified with the full title of the draft

GFI document and the docket number

found in the heading of this document.
3908 Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices

Submit written requests for single

copies of these draft GFI documents to

the Communications and Education

Team (HFV–12), Center for Veterinary

Medicine (CVM), Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Copies of these draft guidance

documents may be obtained on the

Internet from the CVM Home Page

(http://www.cvm.fda.gov).

FOR FURTHER INFORMATION CONTACT:

Regarding the GFI’s: William G.

Marnane, Center for Veterinary

Medicine (HFV–140), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

0678. E-mail:

wmarnane@bangate.fda.gov.

Regarding VICH: Sharon R.

Thompson, Center for Veterinary

Medicine (HFV–3), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–

1798. E-mail:

sthompso@bangate.fda.gov.

SUPPLEMENTARY INFORMATION: In recent

years, many important initiatives have

been undertaken by regulatory

authorities, industry associations, and

individual sponsors to promote the

international harmonization of

regulatory requirements. FDA has

participated in efforts to enhance

harmonization and has expressed its

commitment to seeking scientifically

based harmonized technical procedures

for the development of pharmaceutical

products. One of the goals of

harmonization is to identify and reduce

the differences in technical

requirements for drug development

among regulatory agencies.

FDA has actively participated in the

ICH for several years to develop

harmonized technical requirements for

the registration of human

pharmaceutical products among the

European Union, Japan, and the United

States. The VICH is a parallel initiative

for veterinary pharmaceutical products.

The VICH is concerned with developing

harmonized technical requirements for

the registration of veterinary

pharmaceutical products in the

European Union, Japan, and the United

States, and includes input from both

regulatory and industry representatives.

The VICH meetings are held under the

auspices of the Office International des

E ́pizooties (OIE). During the initial

phase of the VICH, an OIE

representative chairs the VICH Steering

Committee. The VICH Steering

Committee is composed of member

representatives from the European

Commission; the European Medicines

Evaluation Agency; the European

Federation of Animal Health; the U.S.

Food and Drug Administration; the U.S.

Department of Agriculture; the Animal

Health Institute; the Japanese Veterinary

Pharmaceutical Association; and the

Japanese Ministry of Agriculture,

Forestry and Fisheries.

Four observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/ New Zealand,

one representative from the industry in

Australia/ New Zealand, one

representative from MERCOSUR

(Argentina, Brazil, Uruguay and

Paraguay), and one representative from

Federacion Latino-Americana de la

Industria para la Salud Animal. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confe ́de ́ration

Mondiale de L’Industrie de la Sante ́

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

At a meeting held on August 20 and

21, 1997, the VICH Steering Committee

agreed that the draft GFI documents

entitled ‘‘Validation of Analytical

Procedures: Definition and

Terminology’’ and ‘‘Validation of

Analytical Procedures: Methodology’’

should be made available for public

comment. These draft GFI documents

were prepared by the VICH Quality

Working Group and are based on the

ICH Guidelines (Q2A and Q2B) that

have already been adopted by FDA for

human pharmaceuticals. With one

exception, the deletion of the text ‘‘(e.g.

metered dose inhalers)’’ included in the

ICH guideline Q2B, Section 3, the

documents are identical.

The draft GFI document entitled,

‘‘Validation of Analytical Procedures:

Definition and Terminology,’’ discusses

the characteristics that should be

considered during the validation of the

analytical procedures included in an

application for registration of veterinary

medicinal products in the European

Union, Japan, and the United States.

This document pertaining to ‘‘Definition

and Terminology’’ is not intended to

cover testing requirements or

procedures, rather it is intended to serve

as a collection of terms and definitions.

These common definitions such as

‘‘analytical procedures,’’ ‘‘specificity,’’

‘‘precision,’’ ‘‘accuracy,’’ etc., are meant

to bridge the differences that often exist

among various compendia and

requirements of the European Union,

Japan, and the United States. The draft

GFI document entitled, ‘‘Validation of

Analytical Procedures: Methodology,’’

discusses common analytical

procedures and provides guidance and

recommendations on how to consider

various validation characteristics for

each analytical procedure. It also

indicates the data that should be

included in an application for

registration. Comments about these draft

GFI documents will be considered by

the FDA and the VICH Quality Working

Group. Ultimately, FDA intends to

adopt the VICH Steering Committee’s

final guidelines and publish them as

future GFI documents.

If finalized, these documents will

represent current FDA thinking on

characteristics for consideration during

the validation of the analytical

procedures included as part of

applications. The draft GFI documents

will not create or confer any rights for

or on any person and will not operate

to bind FDA or the public. Alternate

approaches may be used if they satisfy

the requirements of applicable statutes,

regulations, or both.

Interested persons may, on or before

March 30, 1998, submit to the Dockets

Management Branch (address above)

written comments on the draft guidance

document. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document and with the

full title of the guidance document. The

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. After

review of these comments, FDA will

implement the guidance document with

any appropriate changes. Thereafter,

interested persons may submit written

comment on the guidance document

directly to the CVM Communications

and Education Team (address above).

Dated: January 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1848 Filed 1–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Information Collection To Be

Submitted to the Office of Management

and Budget (OMB) for Approval Under

the Paperwork Reduction Act

ACTION: Notice.

SUMMARY: The collection of information

described below will be submitted to

OMB for approval under the provisions